At a glance
ClinicalIndex Comparison RecordN/ACompleted· 135 enrolled
Drug / intervention
ABSORB GT1 BVSdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System Post-marketing Surveillance (PMS)
In Brief
A clinical study evaluating ABSORB GT1 BVS for Ischemic Heart Disease and 4 related conditions. Completed, enrolled 135 participants across 15 sites.
Detailed Summary
The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for evaluating clinical use results.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIschemic Heart Disease, Angina Pectoris, Coronary Artery Disease, Coronary Artery Occlusion, Myocardial Ischemia
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
Enrollment StartDec 2016
First PostedJan 2018
Primary CompletionFeb 2023
TodayJul 2026
First PostedJan 24, 2018
Enrollment StartDec 13, 2016
Primary CompletionFeb 6, 2023
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 8.4 years ago
Interventions
ABSORB GT1 BVSdevice
Patients receiving Absorb GT1 BVS